nd annual companion diagnostics & biomarkers · the 2nd annual companion diagnostics &...
TRANSCRIPT
14 - 15 FEBRUARY | PORTO, PORTUGAL
2ND ANNUAL COMPANION
DIAGNOSTICS & BIOMARKERS
2019Co-located with the Biobanking Event
InterContinental Porto - Palácio das Cardosas
Sponsored by:
Learn the recent advances and future perspectives in Companion Diagnostics & Biomarkers
Understand the key aspects & challenges of Clinical Biomarker development & qualification Solutions for cl inical development of precision therapies
Predictive Biomarkers and Companion Diagnostics for Immuno-Oncology
Latest US and EU CDx regulation and guidance
Regulatory landscapes for biomarkers and diagnostic tests
Main barriers to progression of precision medicine in drug development
The Role of In Vitro Diagnostics in Successful Precision Medicine Market Access
Options for biomarker based patient stratification in NON-ONCOLOGY clinical development
Key trends in targeted and immuno-oncology companion diagnostics
Understand how better pharma/payer communications will be essential as more biological drugs with CDx hit the market.
Strategic Partnerships for CDx – Challenges and Opportunities
KEY PRACTICALLEARNING POINTS
The 2nd Annual Companion Diagnostics &
Biomarkers 2019 will provide valued
information about new IVD regulations, Dx
reimbursement strategy, market access
strategy to ensure successful
commercialization with pharma & biotech
companies. We will also provide solutions to
assist in all stages of CDx development from
the biomarker discovery process through CDx
commercialization.
DESCRIPTION
The BioTech Pharma Summit is proud to pre-
sent the 2nd Annual Companion Diagnostics &
Biomarkers 2019. This innovative B2B event
will enable the participants to learn about the
latest trends, developments, business models
and strategies in the companion diagnostics &
Biomarkers.
Companion Diagnostics market is growing due
to continuous advancement in medical techno-
logy both for the diagnosis and the treatment
of patients. Rise in the prevalence of diseases
like cancer & HIV is fueling to the growth of
companion diagnostics as it assist in determi-
ning the patient specific dose and drugs.
Learn the recent advances and future perspectives in Companion Diagnostics & Biomarkers
Understand the key aspects & challenges of Clinical Biomarker development & qualification Solutions for cl inical development of precision therapies
Predictive Biomarkers and Companion Diagnostics for Immuno-Oncology
Latest US and EU CDx regulation and guidance
Regulatory landscapes for biomarkers and diagnostic tests
Main barriers to progression of precision medicine in drug development
The Role of In Vitro Diagnostics in Successful Precision Medicine Market Access
Options for biomarker based patient stratification in NON-ONCOLOGY clinical development
Key trends in targeted and immuno-oncology companion diagnostics
Understand how better pharma/payer communications will be essential as more biological drugs with CDx hit the market.
Strategic Partnerships for CDx – Challenges and Opportunities
KEY PRACTICALLEARNING POINTS
WHO SHOULDATTEND
Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers including:
Companion Diagnostics
Molecular Diagnostics
Personalized Healthcare
Clinical Development
Regulatory Affairs
Molecular Diagnostics
Biomarkers
Medical Sciences
Experimental Medicine
Translational Medicine
Immunology
Genomics
Insurers
Patient Advocates
Payers
Market Access
Commercialization
Oncology
Non-oncology
Rare Diseases
Drug Development
Research
WHO SHOULDATTEND
JOHNQUACKENBUSH
Chair of the Department of Biostatist ics at the Harvard School of Public Health
US
JANE WILKINSON
Senior Director, Genomics Platform Project & Alliance Management at Broad Institute
US
STEFAN KOSTENSE
Director, Biomarkers, Janssen (Johnson & Johnson)
NL
MARIA ORR
Executive Director, Precision Medicine and Genomicsat AstraZeneca
UK
JAMES GODSEY
Vice President,R&D, Clinical Sequencing Division at Thermo Fisher Scientific
US
MARTINA KAUFMANN
Managing Directorat Martina KaufmannStrategic Consulting
DE
JOANNE HACKETT
Chief Commercial Officer atGenomics England
UK
SPEAKERSLIST
DOLORES CAHILL
Professor of Trans-lational Science, UCD School of Medicine, Universi-ty College Dublin
IE
JÖRG ENGELBERGS
Scientific Regula-tory Expert Biome-dicines at Paul-Ehrl ich-Insti-tut (PEI)
DE
CHRISTOPHE LE TOURNEAU
Senior Medical Oncologist & Professor of Medi-cine at Institut Curie & UVSQ
FR
CHRISTA NOEHAMMER
Senior Scientist at the Austrian Insti-tute of Technology
AT
THOMAS HACHDirector Healthcare Systems at Novartis
CH
CARLA LEIBOWITZ
Global headof healthcarepartnershipsat NVIDIA
US
ANA ALFIREVIC
Senior Lecturerat Institute of TranslationalMedicine, University of Liverpool
UK
ANDREAS STANGE
Vice President MHS global IVD at TÜV SÜD
JP
Over 20+ presentations and case studies focu-
sed on the key issues in Companion Diagnostics
& Biomarkers. Join us at the Companion Diag-
nostics & Biomarkers 2019 in Porto
CAROLINA GARCIA RIZO
Chief Business Officer at Just Biotherapeutics
US
JOHNQUACKENBUSH
Chair of the Department of Biostatist ics at the Harvard School of Public Health
US
JANE WILKINSON
Senior Director, Genomics Platform Project & Alliance Management at Broad Institute
US
STEFAN KOSTENSE
Director, Biomarkers, Janssen (Johnson & Johnson)
NL
MARIA ORR
Executive Director, Precision Medicine and Genomicsat AstraZeneca
UK
JAMES GODSEY
Vice President,R&D, Clinical Sequencing Division at Thermo Fisher Scientific
US
MARTINA KAUFMANN
Managing Directorat Martina KaufmannStrategic Consulting
DE
JOANNE HACKETT
Chief Commercial Officer atGenomics England
UK
SPEAKERSLIST
DOLORES CAHILL
Professor of Trans-lational Science, UCD School of Medicine, Universi-ty College Dublin
IE
DAVID HENDERSON
Senior Biologist at Mironid
UK
YONG-JIE LU
Professor in Molecular Oncology at Barts Cancer Institute, Queen Mary Universityof London
UK
CHARLOTTE RYCKMAN
Lawyer at Covington & Burl ing
BE
SIMON PATTON
Director at European Molecular Genetics Quality Network (EMQN)
UK
ALEXANDER BASTIAN
Vice President, Market Access& Pricing at Galapagos
US
PHILIPPE VAN PUT
Chairman of the Nuclear Medicine Awareness Working Group from AIPES
BE
GARY PESTANO
Vice President, Development and Operations at Biodesix , Inc.
US
LAUREN LEIMAN
Executive Director at BloodPAC
US
ALEXANDRE PASSIOUKOV
Vice President Translational Medicine atPierre Fabre
FR
SCIENTIFICAGENDA
DAVID HENDERSON
Senior Biologist at Mironid
UK
YONG-JIE LU
Professor in Molecular Oncology at Barts Cancer Institute, Queen Mary Universityof London
UK
CHARLOTTE RYCKMAN
Lawyer at Covington & Burl ing
BE
SIMON PATTON
Director at European Molecular Genetics Quality Network (EMQN)
UK
ALEXANDER BASTIAN
Vice President, Market Access& Pricing at Galapagos
US
PHILIPPE VAN PUT
Chairman of the Nuclear Medicine Awareness Working Group from AIPES
BE
GARY PESTANO
Vice President, Development and Operations at Biodesix , Inc.
US
LAUREN LEIMAN
Executive Director at BloodPAC
US
ALEXANDRE PASSIOUKOV
Vice President Translational Medicine atPierre Fabre
FR
TRENDS FOR COMPANION DIAGNOSTICS
GLOBAL PERSPECTIVE OF CDX REGULATION
Registration and Welcome Coffee07:30
08:20 Opening Ceremony by Chairman Dr. Thomas Hach
09:00 Speed Networking
10:30 Morning Coffee and Networking Break
08:30 The future of precision medicine By Thomas Hach - Director Healthcare Systems at Novartis
Oncology and genomics: halfway there
Other disease areas and more Omics: we’re just starting
The future: complexity simplified, research put into practice, digital put into action
10:00 Democratization and Globalization of Next Generation Sequencing for Companion Diagnostics By Jim Godsey - Vice President, Research and Development, Clinical Sequencing Division (CSD) at Thermo Fisher Scientific
Developing Biomarkers predicting the risk of onset of disease, for the purpose of developing treatments for disease prevention and interception
09:30
By Stefan Kostense - Director, Biomarkers at Janssen Prevention Center
Thursday, February 14, 2019
11:30 Scientific-Regulatory Challenges for Co-Development of Drug and Companion Diagnostics in EuropeBy Jörg Engelbergs - Scientific-Regulatory Expert, Paul-Ehrlich-Institut
Overview of current CDx regulatory requirements in the EU
Challenges and requirements for analytical assay validation during clinical development
Considerations on complex (multimarker) assays
Ensuring diagnostic assay quality during clinical drug-Dx co-development and clinical routine
11:00 Leveraging RWE to bring value to payers in personalized medicineBy Alexander Bastian - Vice President, Market Access & Pricing at Galapagos
Overview of payer value drivers associated with personalized medicine
Common gaps in the patient journey and payer submissions for personalized medicines
RWE approaches to filling data gaps
Potential challenges in RWE for personalized medicines
12:00 Panel Discussion: Outlook on the CDX regulatory landscape in the EUModerated by Charlotte Ryckman - Lawyer at Covington & Burling
Current regulation of CDx in the EU and the US
CDx under the EU IVD Regulation: scope, and interactions between authorities
Regulatory approaches for novel diagnostic platforms: EU and US aspects
Panelists: Jörg Engelbergs - Scientific-Regulatory Expert, Paul-Ehrlich-Institut | Andreas Stange - Vice President at TÜV SÜD | Martina Kaufmann - Managing Director at Martina Kaufmann Strategic Consulting
DAY 1
13:00 Business Lunch
17:30 Chairman's Closing Remarks
15:00 Afternoon Tea and Networking Break
20:00 Gala Dinner
14:00
By Gary Pestano - Vice President, Development and Operations at Biodesix, Inc.
Biomarker assay development and validation in a CAP/CLIA/NYS CLEP – approved Laboratory
Strategies for successful reimbursement and commercialization of biomarker assays in a centralized Clinical Laboratory
Development and Commercialization of Biomarker Assays for Therapeutic and Diagnostic Guidance in NSCLC
15:30 Liquid biopsy- the future of cancer diagnosis and precision medicine By Yong Jie Lu - Professor in Molecular Oncology, Queen Mary University of London
16:30 Image-based CDx solutions By Carla Leibowitz - Global head of healthcare partnerships at NVIDIA
DEVELOPMENT AND COMMERCIALIZATION OF CDX
ROLE OF IMAGING IN THE ERA OF PRECISION MEDICINE
16:00 Accelerating Development of Liquid Biopsy technologyBy Lauren C. Leiman - Executive Director at BloodPAC
Establishing standards to accelerate development and approval of liquid biopsy technology
White House Cancer Moonshot overview
Technology development process
Creation of standards for pre-analytics, analytics, clinical validation
Example past projects, current projects and future projects
Creation of the BloodPAC Consortium and BloodPAC Data Commons as a commitment to the Cancer Moon-shot and then as an independent entity
BloodPAC Consortium process and project strategies
14:30 Mapping cancer risk SNPs to eQTL networks By John Quackenbush - Chair of the Department of Biostatistics at Harvard T.H. Chan School of Public Health
Biomarkers tend to emphasize individual genes, but genes do not act alone
Instead, genes and genetic variants act as elements of complex interacting networks
These networks and their properties can be used to inform our understanding of disease and to develop pre
LIQUID BIOPSIES IN PRECISION MEDICINE
17:00 Nuclear Medicine Imaging for Diagnosing CancerBy Philippe van Put - Chairman of the Nuclear Medicine Awareness Working Group from AIPES
What is nuclear medicine?
For what is nuclear medicine used?
What are the benefits for the doctor and for the patient?
TRENDS FOR COMPANION DIAGNOSTICS
GLOBAL PERSPECTIVE OF CDX REGULATION
Registration and Welcome Coffee07:30
08:20 Opening Ceremony by Chairman Dr. Thomas Hach
09:00 Speed Networking
10:30 Morning Coffee and Networking Break
08:30 The future of precision medicine By Thomas Hach - Director Healthcare Systems at Novartis
Oncology and genomics: halfway there
Other disease areas and more Omics: we’re just starting
The future: complexity simplified, research put into practice, digital put into action
10:00 Democratization and Globalization of Next Generation Sequencing for Companion Diagnostics By Jim Godsey - Vice President, Research and Development, Clinical Sequencing Division (CSD) at Thermo Fisher Scientific
Developing Biomarkers predicting the risk of onset of disease, for the purpose of developing treatments for disease prevention and interception
09:30
By Stefan Kostense - Director, Biomarkers at Janssen Prevention Center
Thursday, February 14, 2019
11:30 Scientific-Regulatory Challenges for Co-Development of Drug and Companion Diagnostics in EuropeBy Jörg Engelbergs - Scientific-Regulatory Expert, Paul-Ehrlich-Institut
Overview of current CDx regulatory requirements in the EU
Challenges and requirements for analytical assay validation during clinical development
Considerations on complex (multimarker) assays
Ensuring diagnostic assay quality during clinical drug-Dx co-development and clinical routine
11:00 Leveraging RWE to bring value to payers in personalized medicineBy Alexander Bastian - Vice President, Market Access & Pricing at Galapagos
Overview of payer value drivers associated with personalized medicine
Common gaps in the patient journey and payer submissions for personalized medicines
RWE approaches to filling data gaps
Potential challenges in RWE for personalized medicines
12:00 Panel Discussion: Outlook on the CDX regulatory landscape in the EUModerated by Charlotte Ryckman - Lawyer at Covington & Burling
Current regulation of CDx in the EU and the US
CDx under the EU IVD Regulation: scope, and interactions between authorities
Regulatory approaches for novel diagnostic platforms: EU and US aspects
Panelists: Jörg Engelbergs - Scientific-Regulatory Expert, Paul-Ehrlich-Institut | Andreas Stange - Vice President at TÜV SÜD | Martina Kaufmann - Managing Director at Martina Kaufmann Strategic Consulting
INNOVATION IN GENOMIC MEDICINE IMPLEMENTATION
STRATEGIES FOR CDX
Registration and Welcome Coffee08:30
08:50 Opening Address of Day 2
09:00 Bringing cancer genomics into the clinicBy Joanne M. Hackett - Chief Commercial Officer at Genomics England
Genomics England is harnessing the power of the NHS to bring cancer genomics into the clinic
Addressing barriers to clinical adoption such as the practical problems of pharmaco-economics
Incorporating prior biological knowledge
10:00 Should every cancer patient be sequenced?By Christophe Le Tourneau - Senior medical oncologist at the Institut Curie
Tumor sequencing has open the door of precision medicine in oncology
Histology-agnostic treatment of cancer is now a reality with two anti cancer drugs approved across histologies based on specific molecular alterations
While tumor sequencing should be performed in all patients with recurrent cancer, this should not be used to give off-label drugs
09:30 Genomics challenges from a single sample to large clinical studiesBy Jane Wilkinson - Senior Director, Broad Genomics Alliance & Project Management at Broad Institute of MIT and Harvard
Highlighting our process development to tackle difficult samples
Reviewing our capabilities in managing high volumes of data generation and analysis
Collaborating to develop new genomics applications
Globally collaborating with researchers to drive them closer to the cure
Digital and in silico therapeutics
Digital and in silico diagnostics
By Carolina Garcia Rizo - Chief Business Officer at Just Biotherapeutics11:00 The Digital and In Silico Therapeutics Revolution
By Christa Noehammer - Senior Scientist bei AIT Austrian Institute of Technology11:30 Exosome-derived epigenetic biomarkers for saliva diagnostics
Friday, February 15, 2019
10:30 Morning Coffee and Networking Break
PRECISION MEDICINE CLINICAL TRIALS
12:00
By Alexandre Passioukov - Vice President Translational Medicine at Pierre Fabre
Deep understanding of the tumor and the anti-tumor immune response
Biomarker strategies and a comprehensive toolkit for biomarker testing
From Eligibility to CDx: Developping and Implementing Effective Biomarker Strategies for Immuno-Oncology Trials
DAY 2
17:30 Chairman's Closing Remarks
16:00 Afternoon Tea and Networking Break
14:00 A global perspective on BRCA gene testing: a new paradigm for molecular testing in breast and ovarian cancerBy Simon Patton - Director at European Molecular Genetics Quality Network (EMQN)
14:30 Prognostic prostate cancer biomarker By David J P Henderson - Senior Biologist at Mironid
AUTO-IMMUNE DISEASE AND IMMUNO-ONCOLOGY
COMPANION DIAGNOSTICS OUTSIDE ONCOLOGY
Overview of the technologies, tests, costs, health economics, benefits and adverse event profiling
By Dolores J. Cahill - UCD School of Medicine, University College Dublin15:00 Recent Developments in Companion Diagnostics in Auto-immune Disease and Immunooncology
15:30 Companion diagnostic development for oncologyBy Maria Orr - Executive Director, Precision Medicine and Genomics at AstraZeneca
Outline the key steps in companion diagnostic development in oncology
Illustrate the CDx development process using exemplars from the AstraZeneca portfolio
Summarise the key opportunities and challenges associated with CDx development
16:30 Genetic biomarker-based patient stratification in non-oncologyBy Ana Alfirevic - Reader in Pharmacology at University of Liverpool
Clinical development of genetic biomarker panels
Validation of genetic biomarker panels
Implementation of genetic testing into clinical practice
Barriers and facilitators to implementing clinical care pathways
13:00 Business Lunch
12:30 Poster Presentations
INNOVATION IN GENOMIC MEDICINE IMPLEMENTATION
STRATEGIES FOR CDX
Registration and Welcome Coffee08:30
08:50 Opening Address of Day 2
09:00 Bringing cancer genomics into the clinicBy Joanne M. Hackett - Chief Commercial Officer at Genomics England
Genomics England is harnessing the power of the NHS to bring cancer genomics into the clinic
Addressing barriers to clinical adoption such as the practical problems of pharmaco-economics
Incorporating prior biological knowledge
10:00 Should every cancer patient be sequenced?By Christophe Le Tourneau - Senior medical oncologist at the Institut Curie
Tumor sequencing has open the door of precision medicine in oncology
Histology-agnostic treatment of cancer is now a reality with two anti cancer drugs approved across histologies based on specific molecular alterations
While tumor sequencing should be performed in all patients with recurrent cancer, this should not be used to give off-label drugs
09:30 Genomics challenges from a single sample to large clinical studiesBy Jane Wilkinson - Senior Director, Broad Genomics Alliance & Project Management at Broad Institute of MIT and Harvard
Highlighting our process development to tackle difficult samples
Reviewing our capabilities in managing high volumes of data generation and analysis
Collaborating to develop new genomics applications
Globally collaborating with researchers to drive them closer to the cure
Digital and in silico therapeutics
Digital and in silico diagnostics
By Carolina Garcia Rizo - Chief Business Officer at Just Biotherapeutics11:00 The Digital and In Silico Therapeutics Revolution
By Christa Noehammer - Senior Scientist bei AIT Austrian Institute of Technology11:30 Exosome-derived epigenetic biomarkers for saliva diagnostics
Friday, February 15, 2019
10:30 Morning Coffee and Networking Break
PRECISION MEDICINE CLINICAL TRIALS
12:00
By Alexandre Passioukov - Vice President Translational Medicine at Pierre Fabre
Deep understanding of the tumor and the anti-tumor immune response
Biomarker strategies and a comprehensive toolkit for biomarker testing
From Eligibility to CDx: Developping and Implementing Effective Biomarker Strategies for Immuno-Oncology Trials
SPEAKERSBIOGRAPHIES
Thomas Hach, MD, is Director Healthcare Systems for Novartis. He is a member of Novartis‘ Corporate Strategy Group. His passion and expertise are in clinical develop-ment, patient outcomes and precision medicine. He joined Novartis from Boehringer Ingelheim, where he was Global Senior Medical Director, Therapeutic Area Metabolism.
THOMAS HACH, CHDirector Healthcare Systems at Novartis
Charlotte Ryckman is a senior associate in the life scienc-es practice of Covington & Burling, based in Brussels. Ms. Ryckman assists clients across a complex range of regula-tory, legal and procedural matters. Her practice focuses on the European Union rules and on the laws in key EU Member States, including Belgium and The Netherlands.
CHARLOTTE RYCKMAN, BELawyer at Covington& Burling
Ana’s research has been focused on molecular pharmacol-ogy and pharmacogenetics. She has been working on discovery and implementation of genetic factors predis-posing to immune-mediated adverse drug reactions (ADRs). In cardiovascular pharmacology, her research aims at investigating genetic factors predisposing to statin-in-duced myopathy by utilizing next generation sequencing strategy.
ANA ALFIREVIC, UKSenior Lecturerat Institute of Translational Medicine, University of Liverpool
Dr. Pestano leads the Development and Operations depart-ments at Biodesix, a molecular diagnostics company. He is the New York State Clinical Laboratory Evaluation Program (CLEP) Laboratory Director in Boulder, CO of the company’s CLIA, CAP, CLEP, and ISO 13485 -certified laboratory. His experiences in the development of high complexity molecular diagnostics tests includes molecular and proteomic approaches.
GARY PESTANO, USVice President, Development and Operations at Biodesix, Inc.
Jane is a Senior Director at the Broad Institute where she leads the Broad Genomics Alliance Management team. In this role, Jane manages the platform’s external collabora-tions and alliances, overseeing the successful implemen-tation and execution. She also works to ensure that the platform meets complex goals from a variety of scientific project types with specific deliverables and deadlines of partnerships, as well as serving as an advocate for those partnerships.
JANE WILKINSON, USSenior Director, Genomics Platform Project & Alliance Management at Broad Institute
Christa Noehammer currently works as Senior Scientist at the Austrian Institute of Technology where she has been heading the Molecular Medicine research unit for several years. Holding a master degree in Microbiology and a PhD in Biochemistry she has been working in the microarray field since 1999 being involved in the design, production and data analysis of various microarray types thereby mainly focusing on minimally invasive biomarker discov-ery for cancer diagnostics.
CHRISTA NOEHAMMER, ATSenior Scientistat the AustrianInstitute of Technology
Over 100+ delegates representing global
pharmaceutical organisations, leading biotech
companies and internationally renowned
academic institutions will be joining the
Companion Diagnostics & Biomarkers 2019
Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD Product Service. He serves as the global responsible for the In-vitro Diagnostic Devices business line. Dr. Stange joined TÜV SÜD in 2001 as medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he was President & CEO of TÜV SÜD in Japan.
ANDREAS STANGE, JPVice President MHSglobal IVD at TÜV SÜD
Prof. Dr Dolores Cahill has over 25 years expertise in high-throughput protein array, antibody array, proteomics technology development, automation and their biomedi-cal applications, including in biomarker discovery, diag-nostics and personalised medicine. She is Professor of Translational Science, School of Medicine and at the Conway Institute at the University College Dublin (UCD) (2005-present).
DOLORES CAHILL, IEProfessor of Translational Science, UCD School of Medi-cine, University College Dublin
Philippe van Put hold a Master degree in Nuclear Sciences Engineering with a specialty in radiation detection. His graduation work was dedicated to brain imaging by nuclear medicine technic. He hold also a post-university degree in Health Physics and Radiation Protection. He had several expert duties in companies active in the nuclear industry where he served finally as Director of Health Physics product development.
PHILIPPE VAN PUT, BEChairman of the Nuclear Medicine Awareness Working Group from AIPES
Lauren C. Leiman is currently the Executive Director of the Blood Profiling Atlas in Cancer (BloodPAC), a consortium focused on creating an open database for liquid biopsies to accelerate the development of safe and effective blood profiling diagnostic technologies for patient benefit. Prior to running BloodPAC, she was the Senior Director of External Partnerships at White House Cancer Moonshot Task Force during the Obama Administration.
LAUREN LEIMAN, USExecutive Directorat BloodPAC
Stefan Kostense, PhD, Director, Biomarkers, Janssen (Johnson & Johnson). After obtaining his PhD on HIV specific immunity, he joined Crucell/Janssen as a scientist, evaluating vaccine immunogenicity in preclinical models. He has set up up the Clinical Immunology department of 35 FTE, and set up a GLP and GCLP compliant laboratory including LIMS, for the analysis of toxicity and clinical samples, supporting the development of antibody therapeutics and vaccines.
STEFAN KOSTENSE, NLDirector, Biomarkers,Janssen (Johnson & Johnson)
Alex is the Head of Global Value, Access, & Pricing within Global Product Strategy at Incyte Corporation, a innovative biotechnology company that focuses on oncology develop-ment. He leads a function responsible for developing and implementing global pricing and reimbursement strate-gies, including health economics and outcomes research support for all pipeline assets at Incyte. Alex’s role is to determine how to develop, communicate, and capture value for new innovative drugs in markets across the globe.
ALEXANDER BASTIAN, USVice President, Market Access& Pricing at Galapagos
John Quackenbush is Professor of Computational Biology and Bioinformatics and Chair of the Department of Biostatistics at the Harvard TH Chan School of Public Health and Professor of Biostatistics and Computational Biology at the Dana-Farber Cancer Institute. John’s PhD was in Theoretical Physics, in 1992 he received a fellow-ship from the National Institutes of Health to work on the Human Genome Project, which led him from the Salk Institute to Stanford University to The Institute for Genom-ic Research (TIGR) before moving to Harvard in 2005.
JOHN QUACKENBUSH, USChair of the Department of Biostatistics at the Harvard School of Public Health
SPEAKERSBIOGRAPHIES
Thomas Hach, MD, is Director Healthcare Systems for Novartis. He is a member of Novartis‘ Corporate Strategy Group. His passion and expertise are in clinical develop-ment, patient outcomes and precision medicine. He joined Novartis from Boehringer Ingelheim, where he was Global Senior Medical Director, Therapeutic Area Metabolism.
THOMAS HACH, CHDirector Healthcare Systems at Novartis
Charlotte Ryckman is a senior associate in the life scienc-es practice of Covington & Burling, based in Brussels. Ms. Ryckman assists clients across a complex range of regula-tory, legal and procedural matters. Her practice focuses on the European Union rules and on the laws in key EU Member States, including Belgium and The Netherlands.
CHARLOTTE RYCKMAN, BELawyer at Covington& Burling
Ana’s research has been focused on molecular pharmacol-ogy and pharmacogenetics. She has been working on discovery and implementation of genetic factors predis-posing to immune-mediated adverse drug reactions (ADRs). In cardiovascular pharmacology, her research aims at investigating genetic factors predisposing to statin-in-duced myopathy by utilizing next generation sequencing strategy.
ANA ALFIREVIC, UKSenior Lecturerat Institute of Translational Medicine, University of Liverpool
Dr. Pestano leads the Development and Operations depart-ments at Biodesix, a molecular diagnostics company. He is the New York State Clinical Laboratory Evaluation Program (CLEP) Laboratory Director in Boulder, CO of the company’s CLIA, CAP, CLEP, and ISO 13485 -certified laboratory. His experiences in the development of high complexity molecular diagnostics tests includes molecular and proteomic approaches.
GARY PESTANO, USVice President, Development and Operations at Biodesix, Inc.
Jane is a Senior Director at the Broad Institute where she leads the Broad Genomics Alliance Management team. In this role, Jane manages the platform’s external collabora-tions and alliances, overseeing the successful implemen-tation and execution. She also works to ensure that the platform meets complex goals from a variety of scientific project types with specific deliverables and deadlines of partnerships, as well as serving as an advocate for those partnerships.
JANE WILKINSON, USSenior Director, Genomics Platform Project & Alliance Management at Broad Institute
Christa Noehammer currently works as Senior Scientist at the Austrian Institute of Technology where she has been heading the Molecular Medicine research unit for several years. Holding a master degree in Microbiology and a PhD in Biochemistry she has been working in the microarray field since 1999 being involved in the design, production and data analysis of various microarray types thereby mainly focusing on minimally invasive biomarker discov-ery for cancer diagnostics.
CHRISTA NOEHAMMER, ATSenior Scientistat the AustrianInstitute of Technology
Maria Orr graduated from Trinity College, Dublin and completed a PhD in molecular genetics at Sheffield Universi-ty. Following a brief period in academia, Maria moved into the pharmaceutical industry in 1994 where she has been actively involved in the application of genetics to drive drug discovery & development. Maria joined the oncology thera-peutic area of AstraZeneca (AZ) in 2005 where she champi-oned of the use of biomarkers to aid clinical drug develop-ment, focusing primarily on the use of biomarkers to drive patient segmentation.
MARIA ORR, UKExecutive Director, Precision Medicine and Genomicsat AstraZeneca
Mironid Ltd is an innovative drug discovery company focused on delivering new best-in-class therapeutics for kidney disease, inflammation and cancer. David is respon-sible for the efficient and effective delivery of lab based and collaborative research programs covering novel compound development, biomarker discovery and target validation. Prior to taking up this position with Mironid, David won a prestigious Innovation Fellowship at the Salk Institute for biological studies, San Diego, for his work in epigenetic dysregulation in precancerous disease.
DAVID HENDERSON, UKSenior Biologistat Mironid
Dr. Engelbergs is currently working for the Paul-Ehrlich-In-stitut in Langen, Germany, as regulatory-scientific expert and assessor (Quality / CMC and Non-Clinic) for biopharma-ceuticals with focus on Biotechs (Monoclonal Antibodies) and further as expert for IVDs / biomarker based Compan-ion Diagnostics (CDx) and stratified / personalized (Bio-) Medicines. He is involved in the European process of market authorization of biopharmaceuticals, comprising scientific assessments and national / EMA advices. Further activities are assessments of GCP conformity of clinical phase I-III trials, national and third-country (USA, East Asia) GMP inspections, and experimental research on biomarkers.
JÖRG ENGELBERGS, DEScientific RegulatoryExpert Biomedicines atPaul-Ehrlich-Institut (PEI)
Professor Joanne Hackett is the Chief Commercial Officer at Genomics England and lead member of the Business and Investment Committee. As CCO, Joanne is responsi-ble for Genomics England’s industry engagement strategy by developing, managing and accelerating relationships with commercial organisations − creating opportunities for collaboration both nationally and globally. Joanne is a clinical academic with a formidable track record of entrepreneurial success, as she translates academic research into medical and commercial returns.
JOANNE HACKETT, UKChief Commercial Officer at Genomics England
Carolina is the Chief Business Officer of Just Biotherapeu-tics, an AI-driven platform that allows bringing biothera-peutics faster, with lower resources, yet highest quality to the market. Carolina has more than 15 years of strategy, business development, commercial and operational experience within the biopharmaceutical and medical device industries. Carolina was the Global Director, Business Development at Thermo Fisher Scientific, where she was responsible for developing strategic partnerships across the pharmaceutical and healthcare industries for the commercialization of oncology-based diagnostics and companion diagnostics.
CAROLINA GARCIA RIZO, USChief Business Officerat Just Biotherapeutics
Alexandre Passioukov leads translational medicine efforts across oncology, CNS and dermatology therapeutic areas at Pierre-Fabre R&D. Previously, Dr. Passioukov was leading translational medicine programs at Roche (Switzerland) with a special focus on immune-oncology drugs. Prior to joining Roche, Alexandre served as Head of Translational Research at EORTC in Brussels, conducting structural translational medicine activities of European clinical research networks. Alexandre is MD with PhD in biology by Université Catholique de Louvain (UCL), where he was closely involved in the launch of 2 spin-off biotech companies: Coulter Pharma Belgium and Diatos.
ALEXANDRE PASSIOUKOV, FRVice President Translational Medicine at Pierre Fabre
Christophe Le Tourneau is senior Medical Oncologist at the Institut Curie and Professor of Medicine at the Versailles-Saint-Quentin-en-Yvelines University. He is heading the Department of Drug Development and Innovation as well as the Head and Neck Clinic. Christo-phe Le Tourneau was certified in Medical Oncology in 2005 and got his PhD in Clinical Epidemiology in 2007. He did a 2-year Clinical Research Fellowship at Princess Margaret Hospital in Toronto, Canada, in the Drug Devel-opment Program.
CHRISTOPHE LE TOURNEAU, FRSenior Medical Oncologist& Professor of Medicineat Institut Curie & UVSQ
Professor Yong-Jie Lu is a professor in Molecular Oncology at Barts Cancer Institute, Queen Mary University of London. He completed his medical training in 1989, MD in 1992 and PhD in 1995. He did his postdoctoral studies 1995 to 2001 at Cancer Genetics Laboratory, Institute of Cancer Research, London, where he was promoted to a permanent post, senior staff scientist. In 2003, he moved to his current institute to set up a male urological cancer genetic and biomarker study programme. His current research focus on circulating biomarker development, aiming to translate them into cancer diagnosis, prognosis and therapeutic stratification. He published >100 original research papers.
YONG-JIE LU, UKProfessor in Molecular Oncology at Barts Cancer Institute, Queen Mary University of London
Simon Patton, PhD is currently Director of the European Molecular Genetics Quality Network (EMQN) – the global leader in the provision of External Quality Assessment (EQA) schemes to diagnostic laboratories in the fields of genetics and pathology. He trained at the University of Liverpool in marine biology, before doing his doctorate in Genetics at the University of Cambridge. He is currently at Manchester University NHS Foundation Trust. Simon’s work has focussed on global improvement in the standards and quality of diagnostic laboratory testing – a field that he has worked in since 1999 through his involve-ment with the EMQN.
SIMON PATTON, UKDirector at EuropeanMolecular GeneticsQuality Network (EMQN)
Dr. Martina Kaufmann, Managing Director at Martina Kaufmann Strategic Consulting (www.mk-stracon.com) has 15+ years industry experience in the field of personalized medicine – from biomarker validation, companion diagnostics development to implementation of such products in the market. She served in various roles of increasing responsibility in business and development functions in small biotech / diagnostic companies as well as in global pharmaceutical & diagnostics corporations (Hoffmann-La Roche AG, Novartis Pharma AG, Novartis Molecular Diagnostics), where she e.g. led the Herceptin® biomarker / companion diagnostics activities and did build up the oncology biomarker group in Basel, respectively.
MARTINA KAUFMANN, DEManaging Directorat Martina KaufmannStrategic Consulting
Carla Leibowitz is a growth and innovation executive currently leading Corporate Development Arterys, the first company to achieve FDA clearances for several products and a platform that combine cloud computing and artificial intelligence in the medical imaging space. In her role, Carla oversees corporate strategy and planning, business development, geographic expansion and inves-tor relations. She has an MBA from the Stanford Graduate School of Business and engineering degrees from both MIT and Stanford.
CARLA LEIBOWITZ, USGlobal head of healthcare partnerships at NVIDIA
Dr. Godsey has an extensive background (30+ years) in Technology Discovery, Product Development and general management in the infectious disease and cancer diag-nostic industry. He joined Thermo Fisher Scientific in 2015 as the Clinical Sequencing Division was established. He is responsible for all Technology Development, Assay Development, Bioinformatics and Instrument Develop-ment related to Next Generation Sequencing at 7 sites located within the US, including the division’s CLIA laboratory. Dr. Godsey’s Team gained FDA and PMDA approval of the first multi-variant, multi-drug NGS CDx for NSCLC, the Oncomine Dx Target Test.
JAMES GODSEY, USVice President, R&D,Clinical Sequencing Divisionat Thermo Fisher Scientific
Maria Orr graduated from Trinity College, Dublin and completed a PhD in molecular genetics at Sheffield Universi-ty. Following a brief period in academia, Maria moved into the pharmaceutical industry in 1994 where she has been actively involved in the application of genetics to drive drug discovery & development. Maria joined the oncology thera-peutic area of AstraZeneca (AZ) in 2005 where she champi-oned of the use of biomarkers to aid clinical drug develop-ment, focusing primarily on the use of biomarkers to drive patient segmentation.
MARIA ORR, UKExecutive Director, Precision Medicine and Genomicsat AstraZeneca
Mironid Ltd is an innovative drug discovery company focused on delivering new best-in-class therapeutics for kidney disease, inflammation and cancer. David is respon-sible for the efficient and effective delivery of lab based and collaborative research programs covering novel compound development, biomarker discovery and target validation. Prior to taking up this position with Mironid, David won a prestigious Innovation Fellowship at the Salk Institute for biological studies, San Diego, for his work in epigenetic dysregulation in precancerous disease.
DAVID HENDERSON, UKSenior Biologistat Mironid
Dr. Engelbergs is currently working for the Paul-Ehrlich-In-stitut in Langen, Germany, as regulatory-scientific expert and assessor (Quality / CMC and Non-Clinic) for biopharma-ceuticals with focus on Biotechs (Monoclonal Antibodies) and further as expert for IVDs / biomarker based Compan-ion Diagnostics (CDx) and stratified / personalized (Bio-) Medicines. He is involved in the European process of market authorization of biopharmaceuticals, comprising scientific assessments and national / EMA advices. Further activities are assessments of GCP conformity of clinical phase I-III trials, national and third-country (USA, East Asia) GMP inspections, and experimental research on biomarkers.
JÖRG ENGELBERGS, DEScientific RegulatoryExpert Biomedicines atPaul-Ehrlich-Institut (PEI)
Professor Joanne Hackett is the Chief Commercial Officer at Genomics England and lead member of the Business and Investment Committee. As CCO, Joanne is responsi-ble for Genomics England’s industry engagement strategy by developing, managing and accelerating relationships with commercial organisations − creating opportunities for collaboration both nationally and globally. Joanne is a clinical academic with a formidable track record of entrepreneurial success, as she translates academic research into medical and commercial returns.
JOANNE HACKETT, UKChief Commercial Officer at Genomics England
Carolina is the Chief Business Officer of Just Biotherapeu-tics, an AI-driven platform that allows bringing biothera-peutics faster, with lower resources, yet highest quality to the market. Carolina has more than 15 years of strategy, business development, commercial and operational experience within the biopharmaceutical and medical device industries. Carolina was the Global Director, Business Development at Thermo Fisher Scientific, where she was responsible for developing strategic partnerships across the pharmaceutical and healthcare industries for the commercialization of oncology-based diagnostics and companion diagnostics.
CAROLINA GARCIA RIZO, USChief Business Officerat Just Biotherapeutics
Alexandre Passioukov leads translational medicine efforts across oncology, CNS and dermatology therapeutic areas at Pierre-Fabre R&D. Previously, Dr. Passioukov was leading translational medicine programs at Roche (Switzerland) with a special focus on immune-oncology drugs. Prior to joining Roche, Alexandre served as Head of Translational Research at EORTC in Brussels, conducting structural translational medicine activities of European clinical research networks. Alexandre is MD with PhD in biology by Université Catholique de Louvain (UCL), where he was closely involved in the launch of 2 spin-off biotech companies: Coulter Pharma Belgium and Diatos.
ALEXANDRE PASSIOUKOV, FRVice President Translational Medicine at Pierre Fabre
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Super Early BirdUntil October19
500€
1,495€
2,800€
Early BirdUntil November 30
600€
1,695€
3,000€
Discounted TicketUntil January 10
650€
1,795€
3,250€
Normal TicketAfter January 10
850€
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*The 2nd Annual Companion Diagnostics & Biomarkers 2019 is an exclusive limited seat event. Early bird tickets are non-refundable and subject to availability.
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2 Delegates
3 Delegates
4+ Delegates
Until October 19
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15%
20%
Until November 30
5%
10%
15%
Until January 10
-
5%
10%
After January 10
-
-
5%
ACADEMIC/ MED./ NPO PACKAGE
2 days Summit
Full-Access to All Sessions
Coffee Breaks/Lunches
Gala Dinner (Extra 50€)
Unique 1-on-1 meetings
Access to both streams:Biobanking + CDx & Biomarkers
Airport Pick-Up/Drop-Off
Accommodation at the Hotel Venue
Individual or Group RegistrationINDUSTRY BASIC PACKAGE
2 days Summit
Full-Access to All Sessions
Coffee Breaks/Lunches
Gala Dinner
Unique 1-on-1 meetings
Access to both streams:Biobanking + CDx & Biomarkers
Airport Pick-Up/Drop-Off
Accommodation at the Hotel Venue
Individual RegistrationINDUSTRY PREMIUM PACKAGE
2 days Summit
Full-Access to All Sessions
Coffee Breaks/Lunches
Gala Dinner
Unique 1-on-1 meetings
Access to both streams:Biobanking + CDx & Biomarkers
Airport Pick-Up/Drop-Off
Accommodation at the Hotel Venue
Individual Registration
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Diogo Lino RibeiroProject Director, Europe | Porto Office
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Hotel InterContinental Porto - Palácio das CardosasPraça da Liberdade 25, 4000-322 Porto
All Prices displayed include VAT @ The VAT amount will be displayed after the payment process and shown on your invoice.
Name:
Position:
E-mail:
Title:
Name:
Position:
E-mail:
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Academic/ Med./ NPO Package
Industry Package
Premium Package
Super Early BirdUntil October19
500€
1,495€
2,800€
Early BirdUntil November 30
600€
1,695€
3,000€
Discounted TicketUntil January 10
650€
1,795€
3,250€
Normal TicketAfter January 10
850€
1,995€
3,550€
*The 2nd Annual Companion Diagnostics & Biomarkers 2019 is an exclusive limited seat event. Early bird tickets are non-refundable and subject to availability.
REGISTRATION FORM PACKAGE NAME
Team Discounts
2 Delegates
3 Delegates
4+ Delegates
Until October 19
10%
15%
20%
Until November 30
5%
10%
15%
Until January 10
-
5%
10%
After January 10
-
-
5%
ACADEMIC/ MED./ NPO PACKAGE
2 days Summit
Full-Access to All Sessions
Coffee Breaks/Lunches
Gala Dinner (Extra 50€)
Unique 1-on-1 meetings
Access to both streams:Biobanking + CDx & Biomarkers
Airport Pick-Up/Drop-Off
Accommodation at the Hotel Venue
Individual or Group RegistrationINDUSTRY BASIC PACKAGE
2 days Summit
Full-Access to All Sessions
Coffee Breaks/Lunches
Gala Dinner
Unique 1-on-1 meetings
Access to both streams:Biobanking + CDx & Biomarkers
Airport Pick-Up/Drop-Off
Accommodation at the Hotel Venue
Individual RegistrationINDUSTRY PREMIUM PACKAGE
2 days Summit
Full-Access to All Sessions
Coffee Breaks/Lunches
Gala Dinner
Unique 1-on-1 meetings
Access to both streams:Biobanking + CDx & Biomarkers
Airport Pick-Up/Drop-Off
Accommodation at the Hotel Venue
Individual Registration
Address:
VAT No:
Company:
Signature:
City:
Date
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Phone
Gala Dinner
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*Please send the signed form to this contact.
SPONSORSHIP PACKAGES
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ConfirmationWe will confirm your participation after receiving the signed registration form the delegate will receive the invoice within 24h of sending the signed form. The hotel details will be sent 2 or 3 weeks before the start of the conference.CancellationsCancellations made one month prior to the start of the conference will be refunded less 50% administration charge. Refunds will be made after the conference. Cancellations made within one month of the conference start date will receive no refund. Substitutes are accepted up to 3 days before the conference. Any cancellation will be accepted latest one month before the event and should be informed in written form.
Force MajeureWhile every reasonable effort will be made to adhere to the advertised package, EPM Group reserves the right to change event dates, sites or location, omit event features, or merge the event with another event as it deems necessary without penalty and in such situations no refunds, part refunds or alternative offers shall be made (including, but not limited to any force majeure occurence) and provided that the event is not postponed to a later date nor is it merged with another event, the client shall receive a credit note for the amount that the client has paid to such permanently canceled event. No refunds, part refunds or alternative offers shall be made.CopyrightAll Intellectual Property rights in all materials produced or distributed by EPM Group in connection with this event are expressly reserved and any unauthorized duplication, publication or distribution is prohibited.
SILVER SPONSORSHIP
Opportunity to give a speech at the beginning of the conference[up to 40min]8m2 exhibition space with LCD Monitor for Video PresentationsTable & Spiderwall with design customized by the client*FULL page Ad in conference programCompany Banner displayed at all the Sessions including Gala DinnerLogo on the conference website and main stageFlyer/promo gifts into congress bagsBranding at post-event communication activitiesAccess to all Sessions including the Biobanking EventBusiness Lunches & Gala DinnerExclusive One-on-One Meetings Up to 5 delegates FREE-Admission (25% discount for extra ticket)VIP Airport Pick-up Service2 nights accommodation for 5 delegates registered
Speaking slot [up to 40min]6m2 exhibition space with LCD Monitor for Video PresentationsTable & Spiderwall with design customized by the client*½ page Ad in conference programCompany Banner displayed at the reception desk & Coffee breaksLogo on the conference website and main stageFlyer/promo gifts into congress bagsBranding at post-event communication activitiesAccess to all Sessions including the Biobanking EventBusiness Lunches & Gala DinnerExclusive One-on-One Meetings Up to 4 delegates FREE-Admission (25% discount for extra ticket)VIP Airport Pick-up Service2 nights accommodation for 4 delegates registered
GOLD SPONSORSHIP 15,995€(VAT INC.) 12,995€(VAT INC.)
SPEAKER SPONSORSHIP
Speaking slot [up to 40min]6m2 exhibition spaceTable & Spiderwall with design customized by the client*¼ page Ad in conference programCompany Banner displayed at the reception deskLogo on the conference website and main stageFlyer/promo gifts into congress bagsBranding at post-event communication activitiesAccess to all Sessions including the Biobanking EventBusiness Lunches & Gala DinnerExclusive One-on-One Meetings Up to 3 delegates FREE-Admission (25% discount for extra ticket)VIP Airport Pick-up Service2 nights accommodation for 3 delegates registered
Speaking slot [up to 40min]3m2 exhibition spaceTable & Spiderwall with design customized by the client*Logo on the conference website and main stageFlyer/promo gifts into congress bagsBranding at post-event communication activitiesAccess to all Sessions including the Biobanking EventBusiness Lunches & Gala DinnerExclusive One-on-One Meetings Up to 3 delegates FREE-Admission (25% discount for extra ticket)
BRONZE SPONSORSHIP 8,995€(VAT INC.) 5,995€(VAT INC.)
EXHIBITION PACKAGE
Speaking slot [up to 40min]Logo on the conference website and main stageFlyer/promo gifts into congress bagsBranding at post-event communication activitiesAccess to all Sessions including the Biobanking EventBusiness Lunches & Gala DinnerExclusive One-on-One Meetings Up to 2 delegates FREE-Admission (25% discount for extra ticket)
3m2 exhibition spaceTable & Spiderwall with design customized by the client*Logo on the conference website and main stageFlyer/promo gifts into congress bagsBranding at post-event communication activitiesAccess to all Sessions including the Biobanking EventBusiness Lunches & Gala DinnerExclusive One-on-One Meetings Up to 2 delegates FREE-Admission (25% discount for extra ticket)
KEYNOTE SPEECH PACKAGE 3,550€(VAT INC.) 3,550€(VAT INC.)
*Assembly of your space and the design of your booth will be supported by us
Use the Ref. BIOTECH19 and get 10% discount.
To use the discount, please send email to [email protected] or call +351 220 035 600
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